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Analytical Method Development Scientist Jobs in California

Spyglass Pharma

Director, Analytical Development

Aliso Viejo, CA · On-site

$225K - $250K/yr

  • Medical

  • Dental

  • Vision

  • PTO

This role will also lead and mentor a team of analytical scientists responsible for method development, characterization, stability, and testing activities, while playing a key role in developing the ...

Amgen

Process Development Senior Scientist

Thousand Oaks, CA

$96K - $131K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Define analytical control strategies and implement methodologies to support the development of late-phase clinical programs, with a strong ability to articulate the challenges and complexities ...

Amgen, Inc.

Process Development Senior Scientist

Thousand Oaks, CA · On-site

$96K - $131K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Define analytical control strategies and implement methodologies to support the development of late-phase clinical programs, with a strong ability to articulate the challenges and complexities ...

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Analytical Method Development Scientist information

What does an analytical method development scientist do?

An Analytical Method Development Scientist is responsible for designing, developing, and validating analytical methods used to test and analyze chemical compounds, pharmaceuticals, or other materials. They ensure that the methods are accurate, reliable, and compliant with regulatory standards. This role involves working with advanced laboratory instruments, troubleshooting analytical issues, and documenting procedures for use in research, quality control, or manufacturing environments.

What are the key skills and qualifications needed to thrive as an analytical method development scientist?

To thrive as an Analytical Method Development Scientist, a strong background in chemistry, analytical techniques, and method validation—often supported by a relevant degree in chemistry or pharmaceutical sciences—is essential. Familiarity with laboratory instrumentation such as HPLC, GC, MS, and software for data analysis, as well as knowledge of regulatory guidelines like ICH and FDA, is typically required. Attention to detail, problem-solving abilities, and effective communication are vital soft skills for success in this role. These skills ensure reliable method development, regulatory compliance, and effective collaboration within multidisciplinary scientific teams.

What are the typical challenges faced by an analytical method development scientist when transferring methods to quality control or manufacturing teams?

One common challenge for Analytical Method Development Scientists is ensuring that newly developed analytical methods are robust and reproducible when transferred to quality control or manufacturing teams. Differences in equipment, sample matrices, or operator technique can impact results, so thorough method validation and clear documentation are essential. Scientists often work closely with cross-functional teams to provide training, troubleshoot issues, and adapt protocols as needed. Successfully managing these transitions helps maintain product quality and regulatory compliance.

What is the difference between Analytical Method Development Scientist vs Analytical Chemist?

AspectAnalytical Method Development ScientistAnalytical Chemist
Primary FocusDeveloping and validating new analytical methodsPerforming routine analysis and testing
Work EnvironmentResearch labs, R&D departmentsQuality control labs, manufacturing facilities
CredentialsBachelor's or Master's in Chemistry or related field; experience in method developmentBachelor's degree in Chemistry or related field; experience in analytical testing

While both roles involve analytical testing, the Analytical Method Development Scientist primarily focuses on creating and validating new analytical methods, often in research settings. In contrast, the Analytical Chemist typically performs routine testing to ensure product quality in manufacturing or quality control labs.

What are popular job titles related to Analytical Method Development Scientist jobs in California? For Analytical Method Development Scientist jobs in California, the most frequently searched job titles are:
What job categories do people searching Analytical Method Development Scientist jobs in California look for? The top searched job categories for Analytical Method Development Scientist jobs in California are:
Analytical Method Development Scientist jobs near you
Infographic showing various Analytical Method Development Scientist job openings in California as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 14% Part Time, 2% Temporary, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

Scientist/Sr. Scientist, Analytical (San Diego, CA)

Cedent

San Diego, CA • On-site

Full-time

Re-posted 22 days ago

Job description

Client is seeking an Analytical Scientist/Senior Scientist (level dependent on experience) to join the Analytical Development Team. The Scientist/Senior Scientist will be responsible for developing, performing, and qualifying analytical methods in support of cellular nanoparticle platform based new product development for DS/DP and in-process samples. This is a multi-functional role in an agile and fast-paced environment, working on a novel and differentiated cellular nanoparticle technology.
Some of the Essential Duties and Responsibilities
  • Independently design, develop and troubleshoot analytical assays, including but not limited to nanoparticle analysis, lipid analysis, potency assays, ELISA, Western Blot, PCR-based assays, flow cytometry.
  • Lead analytical method development and optimization for biological substances and nanoparticles.
  • Lead method qualification/ validation and transfer to QC team.
  • Proactively drive collaboration with internal and external partners to design and execute analytical studies in support of process development, stability, pre-clinical, and clinical programs.
  • Serve as subject matter expert in cutting-edge technologies and platforms used for bioanalysis and nanoparticle characterization.
  • Perform analytical testing to support DS/DP characterization and process development.
  • Proactively identify assay issues and assay needs to support the company pipeline projects.
  • Author and review corresponding CMC sections in regulatory filings and responses.
  • Author and review assay SOPs, analytical study/qualification protocols and reports.
Qualifications
  • Ph.D. in Biochemistry, Chemistry, Chemical Engineering or related discipline with 2+ years of experience, or M.S. with 5+ years of experience in Biotechnology or Pharmaceutical Industry.
  • Experience in chromatography and other biophysical methods (HPLC/UPLC/CE, DLS, Nanosight, Flow Cytometry, etc.) highly desirable.
  • Hands-on experience in cell-based analytical methods and biologic product characterizations highly desirable.
  • ELISA, Western Blot, PCR-based methods and other bioassay experiences highly desirable.
  • Experience with TFF or microfluidizer is desirable.
  • In-depth knowledge in lipid nanoparticle (LNP) for drug delivery highly desirable.
  • Experience in biologics regulatory submissions (IND, BLA) desirable.
  • Excellent problem-solving skills and verbal and written communication skills.
  • Self-motivated and able to thrive in a dynamic environment.
  • Open-mindedness to learn and share professional knowledge and experience.
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About Cedent

Sourced by ZipRecruiter

CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.

Industry

It services

Company size

11 - 50 Employees

Headquarters location

Plano, TX, US

Year founded

2008

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